StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms

PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 16, 2024

Primary Completion Date

October 16, 2025

Study Completion Date

October 16, 2025

Conditions
Vulvar Lichen Sclerosus
Interventions
DRUG

StrataMGT

StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.

DRUG

Placebo

The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.

Trial Locations (3)

10036

RECRUITING

Centers for Vulvovaginal Disorders, NY, New York

20037

RECRUITING

Centers for Vulvovaginal Disorders, DC, Washington D.C.

33609

RECRUITING

Centers for Vulvovaginal Disorders, FL, Tampa

All Listed Sponsors
collaborator

Stratpharma AG

INDUSTRY

lead

Andrew T. Goldstein, MD

OTHER